MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Pain (1994); Numbness (2415)

Event Date 05/08/2015

Event Type  Injury  

Manufacturer Narrative

Suspect device udi: (b)(4).

Event Description

It was reported that a patient has neuropathy at the lead site.She reported constant pain in the neck, numbness under the chin, and a lead pulling sensation.She also reported that the device has migrated and is experiencing pain from the migration at the chest site.The patient has been referred for surgery.No known surgical interventions have occurred to date.

Event Description

Patient was implanted with vns on (b)(6) 2015.Vns was programmed on on (b)(6) 2015.Initially, the magnet was helping with her seizures.Additional information was received that the patient's vns was removed on (b)(6) 2015.It was removed due to all of patient's symptoms.Patient also had an increase in seizures above her pre-vns baseline and started having convulsions which she did not have prior to vns.Patient never reached therapeutic levels and the device was disabled on (b)(6) 2015.Clinic notes dated (b)(6) 2015 were received indicating that since the patients last visit, patient's vns has shifted down from the original placement spot.Patient has been experiencing painful sensations in the left face and under both sides of her jaw.This spreads down the front of the left side of her neck.Patient describes the pain as pins and needles.This occurs randomly and not just when the vns is stimulation and worsens considerably with magnet mode (higher output current) stimulation.Patient has difficulty with daily activity due to the generator moving around.When the magnet was swiped, significant dystonic pulling of the left face and neck was noted associated with extreme discomfort on the part of the patient.The vns was turned off as a result.Physician's assessment was that the patient's painful facial and neck sensation and dystonic motor movements of the face and neck may represent a spread of electrical current and the entire system should be removed and replaced.Patient visited the hospital on (b)(6) 2015 because of a generalized seizure and an increase in the pain patient also had a convulsion.Noted dated (b)(6) 2015 indicates that the patient's headaches are worse since the increase in vns settings.Patient feels soreness at the vns generator site.It is implanted more medially in the chest wall near the sternum, rather than the axillary area.She feels that her vns has turned and is now vertical.This is pulling on the lead in her neck.Since the surgery, the vns has rotated and dropped inferiorly, placing a weight and stretching burden on the lead attached to the vagal nerve.Patient's normal and magnet mode output current were decreased from 0.5 ma and 0.75 ma to 0.25 ma and 0,5 ma respectively.The explanted products will not be returned to manufacturer unless the patient signs a release form.

• Brand Name: PULSE GEN MODEL 103
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 5088394
• MDR Text Key: 26191775
• Report Number: 1644487-2015-05804
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 08/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/15/2016
• Device Model Number: 103
• Device Lot Number: 4084
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 10/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 31 YR